Corlux (mifepristone) is a new medication that modulates the body's use of a hormone called cortisol. Under normal conditions, cortisol and other hormones are created by the body in response to physical and emotional stress, triggering a healthy stress response. People who suffer from psychotic major depression may have unusually high levels of cortisol circulating within them or abnormal patterns of cortisol levels, overloading the stress response mechanism and causing symptoms of psychosis such as delusional thoughts or hallucinations. If Corlux can keep the body's cortisol receptors from being overloaded, the stress response system may return to normal function, which may result in improvement of symptoms. The purpose of this 56 day study is to learn the safety and effectiveness of Corlux in patients who have been diagnosed with psychotic major depression (PMD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
443
mifepristone 300 mg daily for 7 dats
daily for 7 days
mifepristone 600 mg daily for 7 days
mifepristone 1200 mg daily for 7 days
K&S Research Services
Little Rock, Arkansas, United States
Center for Emotional Fitness
Cerritos, California, United States
Harbor Medical Associates, Inc.
Fountain Valley, California, United States
Synergy Clinical Research Center
National City, California, United States
Excell Research
Oceanside, California, United States
The change in a measure of psychosis
Time frame: screen, Days 0, 7, 14, 28, 42, 56
The change in a measure of depression
Time frame: screen, Days 0,7, 14, 28, 42, 56
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Pacific Clinical Research Medical Group
Riverside, California, United States
AV Institute, Inc.
Torrance, California, United States
Neuropsychiatric Institute of Orange County
Westminster, California, United States
Geriatric and Adult Psych
Hamden, Connecticut, United States
Comprehensive NeuroScience, Inc.
Washington D.C., District of Columbia, United States
...and 34 more locations